Protocol summary

Summary
Objective: Comparison between the effects of individual and group education on sexual function and satisfaction in menopausal women. Research entrance criteria: Married menopausal women; those aged 45-60 years old; obtaining the score 50-100 on the sexual satisfaction test questionnaire; obtaining lower than 5/26 on the sexual function index test. Research exclusion criteria: Individual’s or her husband’s suffering from any medical disease. Statistical population: All the menopausal women referring to Andimeshk Health and Treatment Center, Khouzestan Province, Iran. The sample size included 60 patients. The individuals were randomly placed into two groups. In individual education, the participants receive four 60-minute sexual training sessions in the form of lecture as well as question and answer (once a week) over one month. In group education, the participants receive four 60-to-90-minute sexual training sessions in the form of lecture as well as question and answer at the Health Center (once a week) over one month. Training sessions include : session (1): menopause and sexual physiologic changes; session (2): women’s sexual function; session (3): women’s sexual satisfaction; and session (4): conclusion and treatment strategies. At entering the study, some questionnaires on women’s demographic data, sexual satisfaction, and sexual function index are completed for all the samples. The individuals, who obtain 50-100 on the sexual satisfaction test questionnaire and lower than 5/26 on sexual function index questionnaire, are selected for the study. Then, sexual function index and sexual satisfaction questionnaires are completed for the individuals in both groups one and four weeks after training, and the results are then compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014080518700N1
Registration date: 2014-10-04, 1393/07/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-04, 1393/07/12
Registrant information
Name
Masoumeh Jafarzadeh
Name of organization / entity
Univercity Medical Siences Jondishapour Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8331
Email address
jafarzadeh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor, Research Development Office, Ahvaz Jundishapour University of Medical Sciences (AJUMS)
Expected recruitment start date
2014-07-18, 1393/04/27
Expected recruitment end date
2014-09-18, 1393/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of individual and group education on sexual function and satisfaction among postmenopausal women in I ran.
Public title
Comparison the effects of individual and group education on sexual function and satisfaction among postmenopausal women in I ran.
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria to enter the study: Married postmenopausal women; women who have passed a minimum of one year and a maximum of five years since their last menstrual period; those aged 45 to 60 years;those with physical and mental health; those obtaining a score of 50-100 on the Sexual Satisfaction Test Questionnaire; the women who obtain a score less than 26/5 on the Sexual Function Index Test Questionnaire; those who can read and write. Criteria for exclusion from the study: A history of induvidual's and her spouse's suffering from any medical disease ; Occurrence of any stressful event over the past two months (e.g., death of a loved one); occurrence of physical and mental problems for menopausal women; drug addiction; Sexually transmitted diseases affecting sexual function.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapour University of Medical Sciences (AJUMS)
Street address
Faculty of Nursing & Midwifery, Ahvaz Jundishapour University of Medical Sciences (AJUMS), Golsetan Blvd.
City
Ahvaz
Postal code
61357-15749
Approval date
2014-07-16, 1393/04/25
Ethics committee reference number
ajums.rct.1393.86

Health conditions studied

1

Description of health condition studied
Satisfaction and sexual dysfunction in menopausal women
ICD-10 code
f52.8
ICD-10 code description
Other sexual dysfunctions not caused by organic disorder or disease

Primary outcomes

1

Description
Sexual satisfaction
Timepoint
Before intervention.One and four weeks after the intervention
Method of measurement
Sexual Satisfaction Questionnaire

Secondary outcomes

1

Description
Sexual dysfunction
Timepoint
Before intervention.One and four weeks after the intervention
Method of measurement
Sexual Dysfunction Questionnaire

Intervention groups

1

Description
"Intervention group: Four individual sexual training sessions for 60 minutes once a week"
Category
Lifestyle

2

Description
"Control group : Four group sexual training sessions for 1-1.5 hours once a week."
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Health & Treatment Center No.1, Andimeshk
Full name of responsible person
Masoumeh Jafarzadeh
Street address
Opposite Social Security Organization (SSO), Sina Ave., Andimeshk
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research Development, Ahvaz Jundishapour University of Medical Sciences (AJUMS)
Full name of responsible person
Dr. Nader Saki
Street address
Research Development Deputyship, Ahvaz Jundishapour University of Medical Sciences (AJUMS)
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research Development, Ahvaz Jundishapour University of Medical Sciences (AJUMS)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences (AJUMS)
Full name of responsible person
Masoumeh Jafarzadeh
Position
Master's (MSc) degree in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Ahvaz Jundishapour University of Medical Sciences (AJUMS), Golestan Blvd.
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1373 8331
Fax
+98 61 1373 8333
Email
Parvin abedi@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences (AJUMS)
Full name of responsible person
Dr Parvin Abedi
Position
PhD in nutrition
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Ahvaz Jundishapour University of Medical Sciences (AJUMS), Golestan Blvd.
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1373 8331
Fax
+98 61 1373 8333
Email
parvinabedi@ymail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences (AJUMS)
Full name of responsible person
Masoumeh jafarzadeh
Position
Master's (MSc) degree in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Ahvaz Jundishapour University of Medical Sciences (AJUMS), Golestan Blvd.
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1373 8331
Fax
+98 61 1373 8333
Email
jafarzadeh_masoumeh@yahoo.com , jafarzadeh.m@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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